Guidance for the application of Article 34 of Regulation (EU) 2019/6 - prescription status
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Consideration of whether a product is subject to veterinary prescription or not is an outcome of product assessment and therefore requires detailed consideration. Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC establishes, in Article 34, the legal framework for the classification of veterinary medicinal products. Whilst some of the provisions in Article 34 of Regulation (EU) 2019/6 are relatively clear-cut, some others will benefit from further elaboration. It is the intention of the guideline to provide clear guidance for the practical application of the provisions in Article 34 of Regulation (EU) 2019/6. To ensure a consistent implementation and a harmonised EU approach, the assessment principles for the various provisions of Article 34 of Regulation (EU) 2019/6 are laid out.
Keywords: VMP Regulation implementation, classification of veterinary medicinal products, veterinary prescription, non – Prescription Only Medicine – Veterinary (non-POM-V)
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Draft guideline on the application of Article 34 of Regulation (EU) 2019/6 - Classification of veterinary medicinal products (prescription status) (PDF/387.49 KB)
Draft: consultation closed
First published: 22/07/2022
Consultation dates: 22/07/2022 to 31/10/2022
EMA/CVMP/273040/2022 -
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Overview of comments received on CVMP guideline on NVR Art 34 for the classification of VMPs (PDF/460.78 KB)
First published: 27/01/2023
EMA/CVMP/855384/2022 -
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Concept paper on the elaboration of guidance for the application of Article 34 of Regulation (EU) 2019/6 (PDF/166.45 KB)
Draft: consultation closed
First published: 25/03/2022
Consultation dates: 25/03/2022 to 30/04/2022
EMA/CVMP/65618/2022